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. 2011 Oct-Dec;79(4):817-36.
doi: 10.3797/scipharm.1107-18. Epub 2011 Oct 13.

Identification of major degradation products of ketoconazole

Rajendra A Mhaske  1 , Shirish Sahasrabudhe
Affiliations

Identification of major degradation products of ketoconazole

Rajendra A Mhaske et al. Sci Pharm. 2011 Oct-Dec.

Abstract

Analytical methods were developed for the identification of major degradation products of Ketoconazole, an antifungal agent. The stressed degradation of Ketoconazole drug substance was performed under acid, base, thermal, photo and oxidative stress conditions. The major degradation was observed under acid, base and oxidative stress conditions. The degradation study was performed on Inertsil ODS-3V, length 100 X diameter 4.6 mm, particle size 3 μm column using gradient method. These degradants were identified by LC-MS technique.

Keywords: Hydrolysis degradent; Ketoconazole; LC-MS; Oxidative degradent; Stress degradation.

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Figures

Fig. 1
Fig. 1
HPLC Chromatograms for Stressed conditions
Fig. 1
Fig. 1
HPLC Chromatograms for Stressed conditions
Fig. 1
Fig. 1
HPLC Chromatograms for Stressed conditions
Fig. 1
Fig. 1
HPLC Chromatograms for Stressed conditions
Fig. 2
Fig. 2
HPLC Chromatograms for preparation Oxidative degradent
Fig. 3
Fig. 3
LC-Mass spectrum for Ketoconazole and degradent products
Fig. 3
Fig. 3
LC-Mass spectrum for Ketoconazole and degradent products
Fig. 3
Fig. 3
LC-Mass spectrum for Ketoconazole and degradent products
Fig. 4
Fig. 4
Mass fragmentation behavior of Ketoconazole and N-Oxide
Fig. 5
Fig. 5
NMR Spectrum of Ketoconazole and N-Oxide
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Fig. 6
Elemental analysis for Ketoconazole and degradent products
Sch. 1
Sch. 1
Structure of elucidated compounds
See this image and copyright information in PMC

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